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Washington Post- Senators Offer Their Support to F.D.A. Nominee

Washington Post- Senators Offer Their Support to F.D.A. Nominee

By Gardiner Harris, The Obama administration’s choice to lead the Food and Drug Administration breezed through her Senate confirmation hearing on Thursday while the administration proposed a budget that would give the agency more money


Skip to next paragraph Dr. Margaret A. Hamburg’s confirmation was all but assured when Senator Orrin G. Hatch, Republican of Utah, strongly endorsed her. “I want you to know that I support you,” Mr. Hatch said, “and I intend to help you not only to get through this process but to do your job out there.”

Mr. Hatch’s endorsement was followed by those of Senator Richard M. Burr, Republican of North Carolina, as well as every Democrat at the hearing of the Senate Health, Education, Labor and Pensions Committee.

One reason for the enthusiasm for Dr. Hamburg may be the unease many conservatives have expressed about Dr. Joshua M. Sharfstein, the agency’s acting commissioner, who will become principal deputy commissioner when Dr. Hamburg is confirmed.

Dr. Sharfstein once worked at the advocacy organization Public Citizen and served on the staff of Representative Henry A. Waxman, a California Democrat who is a fierce critic of the drug industry.

Mr. Hatch, closely allied with drug makers, wondered aloud why the Obama administration had appointed Dr. Sharfstein and asked Dr. Hamburg how she would split her responsibilities with him. She said she would be the agency’s only commissioner.

“I believe that there were reports in the press that were quite misleading,” Dr. Hamburg said. The reports suggested “that I would focus on food and tobacco, should that become part of the F.D.A.’s mandate, and he would focus on drugs. That is simply untrue,” she added.

In her opening remarks, Dr. Hamburg said that she would take an active role in the government’s decision about what vaccine to make in response to the swine flu outbreak. She said she would make a priority of improving oversight of food safety.

The committee may vote as soon as next week to send the nomination to the full Senate.

Before Dr. Hamburg’s hearing, the Obama administration announced that it had proposed increasing the F.D.A.’s budget next year by 19 percent, including $295 million in allocated money and $215 million in additional industry user fees. Half of the increase would go to food safety efforts.

The administration proposed collecting $94 million in fees from food companies, a tax that would require Congressional approval.

The administration also proposed collecting $47 million in fees from makers of generic drugs to help finance the staff needed to reduce a backlog of years in generic drug applications. Kathleen Jaeger, president of the Generic Pharmaceutical Association, said her industry would support such fees “so long as there are guarantees that the fees would result in the timely review and approval of generic applications.”